berkley and jensen clearlax

Product NDC: 68391-306
11-digit product format: 683910306
Labeler code: 68391
Product ID: 68391-306_96160276-65ec-4a20-b8e0-c8c38a87bc6a
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: BJWC
Application: ANDA090685
Marketing category: ANDA
Marketing start: 2009-12-17
Substance: POLYETHYLENE GLYCOL 3350
Active strength: 17 g/17g
Pharmacologic classes: Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68391-306	68391-306-03	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090685-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2009-10-06
A090685-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090685-001	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090685-002	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: berkley and jensen clearlax
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYETHYLENE GLYCOL 3350	17 g/17g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G2M7P15E5P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
876193	Internal RxNorm lookup
880407	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f9eb9023-c83b-49b4-af82-d8344ffa46c3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68391-306-02	berkley and jensen clearlax	765 g in 1 BOTTLE	POWDER, FOR SOLUTION	765	9
68391-306-03	berkley and jensen clearlax	2 in 1 PACKAGE	POWDER, FOR SOLUTION	2	9
68391-306-03	berkley and jensen clearlax	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	BERKLEY AND JENSEN CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BJWC]	5
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	BERKLEY AND JENSEN CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BJWC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-306	BERKLEY AND JENSEN CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BJWC]	9	Current NDC, Legacy NDC, 3 package rows	20230617_f9eb9023-c83b-49b4-af82-d8344ffa46c3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clear lax	POLYETHYLENE GLYCOL 3350	HyVee Inc	5bcf01d8-ddf3-4e64-8d3f-3526a51a5859	2026-07-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
CLEARLAX	POLYETHYLENE GLYCOL 3350	Safeway	a70f41d0-0fad-4d15-8844-d60eabeb6732	2026-07-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	7ed915ec-7e99-4e0e-aca0-20718987a88c	2026-07-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
smooth lax	POLYETHYLENE GLYCOL 3350	Walgreen Company	3027af65-2f7f-472d-83f5-254d5d75013c	2026-05-08	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
clear lax	POLYETHYLENE GLYCOL 3350	Meijer Distribution Inc	6464f12c-0883-46c5-943b-a84fe235588e	2026-04-13	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
equate clear lax	POLYETHYLENE GLYCOL 3350	Wal-Mart Stores Inc	56a507f3-0cd1-4f02-9dfd-de297ba4bc1f	2026-03-27	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
foster and thrive clearlax	POLYETHYLENE GLYCOL 3350	Strategic Sourcing Services LLC	684e35cc-5a4f-458d-b5e7-e1933fea1139	2026-03-07	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Topcare ClearLax	POLYETHYLENE GLYCOL 3350	Topco Associates LLC	03291fd3-7b64-4b79-ad84-e1b9b30a6b03	2026-02-19	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals Inc.	935f05da-3637-4a9e-843e-1f2ced5d1a74	2026-01-23	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
MiraLAX Orange Flavor	POLYETHYLENE GLYCOL 3350	Bayer HealthCare LLC.	0a5b2121-928f-8f49-e063-6394a90a8aaf	2025-12-04	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	A-S Medication Solutions	4f31a33e-1f60-4aa7-b1dc-a3c011c03a70	2025-10-29	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Laxative	POLYETHYLENE GLYCOL 3350	Rite Aid Corporation	457f5d2d-4595-482a-9ffa-659fb5d5b134	2025-10-09	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Bryant Ranch Prepack	5df518fb-ad58-4f17-af34-f66066f1313a	2025-09-30	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
Dulcolax	POLYETHYLENE GLYCOL 3350	Chattem, Inc.	ed16d0f4-74e7-4fa3-989d-c6840a5d3e71	2025-09-30	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
kirkland signature laxaclear original prescription strength	POLYETHYLENE GLYCOL 3350	Costco Wholesale Company	f58fa5c0-8ab7-4427-aea0-d536b47acbb5	2025-09-18	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
up and up powderlax	POLYETHYLENE GLYCOL 3350	Target Corporation	1bceb457-b24f-485d-bfe2-af4b7d38a5c2	2025-09-18	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
clearlax	POLYETHYLENE GLYCOL 3350	Meijer, Inc.	8cca18a8-94f6-43f6-bdb7-2d44a6cdf151	2025-08-08	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
good neighbor pharmacy clearlax	POLYETHYLENE GLYCOL 3350	Amerisource Bergen	e0b419b6-6ce0-4aaa-948f-dee5b2ec2082	2025-04-17	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	006a9eca-400f-47f5-bee5-facf7034043e	2025-03-21	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685
clear lax	POLYETHYLENE GLYCOL 3350	H E B	bd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab	2024-12-02	Warnings	Exact identifier application applno (ANDA): 090685 application number: ANDA090685

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
880407	ClearLax 17 GM Powder for Oral Solution	PSN	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9
880407	polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]	SBD	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9
880407	ClearLax 17 GM Powder for Oral Solution	SY	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	f9eb9023-c83b-49b4-af82-d8344ffa46c3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68391-306-02	68391030602	765 g in 1 BOTTLE (68391-306-02)	765 g	2017-01-20	0000-00-00	No	No	Current
68391-306-03	68391030603	2 in 1 PACKAGE						Historical